The Role of Intra-articular Injection of PRP Versus Corticosteriods in Treatment of Lumbar Facet Disease

NCT04860531 | Completed Phase 3 DMC

• 1 other identifier: FMASU MD 222 / 2017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain is an extremely common health problem and recent studies have shown that nearly up to 52% of patients have low back pain caused by lumbar facet joint syndrome. Intra-articular injection of facet joints has gradually become one of the vital therapeutic methods for lumbar facet joint syndrome, Steroid is one of the most commonly used injected drugs; however, previous studies have indicated that it has limited ability in long-term relief of low back pain. Therefore, it seems meaningful to apply a new injectable drug and to prove its effectiveness and safety for the treatment of lumbar facet joint syndrome. Recent studies indicate that autologous platelet rich plasma(PRP) is an appropriate injectable material with great potential in treating many different musculoskeletal disorders and currently it is not yet used on a wide scale as a treatment for lumbar facet joint synovitis. In this study the investigators compare the efficacy and safety of Intra-articular injection of PRP versus conventional steriods in patients with lumbar facet joint synovitis.

Conditions

Lumbar Facet Joint Syndrome

Keywords

Platelet Rich Plasma

Outcome Measures

Primary Outcomes (6)

• The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing total number of lumbar facet joints showing tenderness on palpation on clinical examination

  In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of total Number of lumbar facet joints showing tenderness on palpation in each participant documented just before the intervention and at 3 month after the intervention

  at 3 month follow up post intervention for each patient

• The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing maximum active lumber extension angle measured by goniometer

  In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Maximum active lumber extension measured by goniometer in each participants documented just before the intervention and at 3 month after the intervention

  at 3 month follow up post intervention for each patient

• The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing the Visual analogue score (VAS)

  In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Visual analogue score documented just before the intervention and at 3 month after the intervention where score of 0 denotes absence of pain and score of 10 denotes maximum pain and decrease in the sore denotes improvement as regards low back pain reported by the participants

  at 3 month follow up post intervention for each patient

• The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing Roland Morris Disability questionnaire score (RMQ)

  In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Roland Morris Disability questionnaire score (RMQ) documented just before the intervention and at 3 month after the intervention, where score 0 denotes absence of any disability and score of 24 denotes maximum disability of the participants and decrease in the score documented denotes improvement

  at 3 month follow up post intervention for each patient

• The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing Functional questionnaire score - Oswestry Disability Index ODI

  In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Oswestry Disability Index score (ODI) documented just before the intervention and at 3 month after the intervention, where score of 0% denotes fully functional participants and score of 100% denotes maximum functional affection and decrease of the score by 10% denotes significant improvement

  at 3 month follow up post intervention for each patient

• The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing number of lumbar facet joints showing synovitis on MRI and/or improving the grade of severity of the synovitis

  In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of number of lumbar facet joints showing synovitis on MRI and/or improving (decrease in) the grade of severity of the synovitis graded from 0 to 4 according to the extent of lumber facet joint synovitis on MRI documented just before the intervention and at 3 month after the intervention

  at 3 month follow up post intervention for each patient

Study Arms (2)

Group (I) Platelet Rich Plasma

ACTIVE COMPARATOR

The participants are randomly assigned for intra-articular injection with autologous platelet rich plasma . The treated segments are determined by clinical signs and MRI detected facet joint synovitis .

Drug: Lumbar Facet Joints intra-articular injection with Platelet Rich Plasma

Group (II) Corticosteroids

ACTIVE COMPARATOR

The participants are randomly assigned for intra-articular injection with corticosteroids(a mixture of 0.5% lidocaine and 5mg/ml of betamethasone) . The treated segments will be determined by clinical signs and MRI detected facet joint synovitis .

Drug: Lumbar Facet Joints intra-articular injection with a mixture of 0.5% lidocaine and 5mg/ml of betamethasone

Interventions

Lumbar Facet Joints intra-articular injection with Platelet Rich Plasma DRUG

Floroscopy guided by C-arm Intraarticular injection in Lumbar facet Joints

Group (I) Platelet Rich Plasma

Lumbar Facet Joints intra-articular injection with a mixture of 0.5% lidocaine and 5mg/ml of betamethasone DRUG

Lumbar Facet Joints intra-articular injection

Group (II) Corticosteroids

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Continuous or intermittent gradually progressive back pain for more than 3 months not significantly improving on medical treatment and/or physical modalities.
• Patients age between 20 and 40 years.
• Local / paraspinal pain or tenderness with or without radiation to buttock , groin or thigh.
• Increase of pain on extension , rotation or lateral bending .
• MRI detected synovitis of the facet joint as defined and graded by Czervionke and Fenton, 2008.

You may not qualify if:

• Acute low back trauma, fractures, malignancies and inflammatory diseases.
• Pain score of \< 4 at rest on visual analog scale.
• Radicular neurologic complaints.
• X-ray findings of long standing facet joint disease as; marked joint space narrowing, subchondral sclerosis or bone deformity/ sponylolithesis.
• Evident disc herniation by MRI.
• Prior surgery on the spine.
• Prior interventional treatment on lumbar facet joints
• Known hypersenstivity to local anesthesia, corticosteroid, contrast medium or blood derivatives.
• Local or systemic infection or spinal infection.
• Uncorrectable coagulopathy
• Diabetes Mellitus
• Pregnancy

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, Egypt

Location

Related Publications (12)

• Wu J, Du Z, Lv Y, Zhang J, Xiong W, Wang R, Liu R, Zhang G, Liu Q. A New Technique for the Treatment of Lumbar Facet Joint Syndrome Using Intra-articular Injection with Autologous Platelet Rich Plasma. Pain Physician. 2016 Nov-Dec;19(8):617-625.

  PMID: 27906940 BACKGROUND

• Wu J, Zhou J, Liu C, Zhang J, Xiong W, Lv Y, Liu R, Wang R, Du Z, Zhang G, Liu Q. A Prospective Study Comparing Platelet-Rich Plasma and Local Anesthetic (LA)/Corticosteroid in Intra-Articular Injection for the Treatment of Lumbar Facet Joint Syndrome. Pain Pract. 2017 Sep;17(7):914-924. doi: 10.1111/papr.12544. Epub 2017 Feb 22.

  PMID: 27989008 BACKGROUND

• Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.

  PMID: 6450426 BACKGROUND

• Czervionke LF, Fenton DS. Fat-saturated MR imaging in the detection of inflammatory facet arthropathy (facet synovitis) in the lumbar spine. Pain Med. 2008 May-Jun;9(4):400-6. doi: 10.1111/j.1526-4637.2007.00313.x.

  PMID: 18489631 BACKGROUND

• Cohen SP, Raja SN. Pathogenesis, diagnosis, and treatment of lumbar zygapophysial (facet) joint pain. Anesthesiology. 2007 Mar;106(3):591-614. doi: 10.1097/00000542-200703000-00024.

  PMID: 17325518 BACKGROUND

• Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4. doi: 10.1097/00007632-198303000-00004. No abstract available.

  PMID: 6222486 BACKGROUND

• Sae-Jung S, Jirarattanaphochai K. Outcomes of lumbar facet syndrome treated with oral diclofenac or methylprednisolone facet injection: a randomized trial. Int Orthop. 2016 Jun;40(6):1091-8. doi: 10.1007/s00264-016-3154-y. Epub 2016 Mar 18.

  PMID: 26987980 BACKGROUND

• Zhang J, Middleton KK, Fu FH, Im HJ, Wang JH. HGF mediates the anti-inflammatory effects of PRP on injured tendons. PLoS One. 2013 Jun 28;8(6):e67303. doi: 10.1371/journal.pone.0067303. Print 2013.

  PMID: 23840657 BACKGROUND

• Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.

  PMID: 24665116 BACKGROUND

• Maas ET, Juch JN, Ostelo RW, Groeneweg JG, Kallewaard JW, Koes BW, Verhagen AP, Huygen FJ, van Tulder MW. Systematic review of patient history and physical examination to diagnose chronic low back pain originating from the facet joints. Eur J Pain. 2017 Mar;21(3):403-414. doi: 10.1002/ejp.963. Epub 2016 Oct 10.

  PMID: 27723170 BACKGROUND

• Manchikanti L, Datta S, Gupta S, Munglani R, Bryce DA, Ward SP, Benyamin RM, Sharma ML, Helm S 2nd, Fellows B, Hirsch JA. A critical review of the American Pain Society clinical practice guidelines for interventional techniques: part 2. Therapeutic interventions. Pain Physician. 2010 Jul-Aug;13(4):E215-64.

  PMID: 20648212 BACKGROUND

• Kotb SY, Sherif NM, Saleh HA, Ahmed SF, Sakr HM, Taeimah MO. The role of intra-articular injection of autologous platelet-rich plasma versus corticosteroids in the treatment of synovitis in lumbar facet joint disease. Saudi Med J. 2022 Nov;43(11):1200-1208. doi: 10.15537/smj.2022.43.11.20220449.

  PMID: 36379530 DERIVED

MeSH Terms

Interventions

Lidocaine; Betamethasone

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Nahed Monir, Professor

  Faculty of Medicine Ain Shams University

  STUDY DIRECTOR

• Hala Abdelhady, Professor

  Faculty of Medicine Ain Shams University

  STUDY DIRECTOR

• Sahar Fathy, Professor

  Faculty of Medicine Ain Shams University

  STUDY DIRECTOR

• Hossam Sakr

  Faculty of Medicine Ain Shams University

  STUDY DIRECTOR

• Mohamed Taeimah, MD

  Faculty of Medicine Ain Shams University

  STUDY DIRECTOR

• Shahdan Kotb

  Faculty of Medicine Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Physical medicine and Rehabilitation

Model Details: The participants are assigned for intra-articular injection of lumbar facet joint to either; Group (I) to be injected with autologous platelet rich plasma and Group (II) to be injected with corticosteroids(a mixture of 0.5% lidocaine and 5mg/ml of betamethasone) . The treated segments will be determined by clinical signs and MRI detected facet joint synovitis .

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: April 27, 2021
• Study Start: September 17, 2019
• Primary Completion: January 22, 2021
• Study Completion: January 22, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-05

Locations

EG (1)